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Colorectal Cancer: S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery

Research Question:
What are the good and bad effects of using a combination of antibodies called trastuzumab and pertuzumab compared to using the usual chemotherapy of cetuximab and irinotecan?

Basic Study Information

Purpose:
If you decide to participate in this study a computer will assign you to one of the 3 study groups. This is done by chance because no one knows if one study group is better or worse than the other. Group 1 will receive the study drugs trastuzumab and pertuzumab. The combination of trastuzumab and pertuzumab is investigational (not approved by the FDA for treatment of colorectal cancer). These drugs will be given through a vein on Day 1 of every 21 day cycle. Group 2 will receive the usual chemotherapy, cetuximab and irinotecan, through a vein on Day 1 of every 14 day cycle. If you are in Group 2 and your cancer gets worse, you may have the option to receive the same treatment as Group 1, and be placed into Group 3.

Location: Cancer Center
Study Web URL:  https://clinicaltrials.gov/ct2/show/NCT03365882?term=S1613&rank=1
Study Reference #: CGIC17126

Lead Researcher (Principal Investigator)

Lead Researcher: Marcus Noel

Study Contact Information

Study Coordinator: Tanya Smith
Phone: (585) 275-8213
Email: Tanya_Smith@URMC.Rochester.edu

Additional Study Details

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